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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

This looks like a 510(k) premarket notification for examination gloves, which are low-risk devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the device meets established ASTM standards and FDA requirements for such products, rather than clinical efficacy trials common for higher-risk medical devices.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The asterisk indicates "the average results from Attachment C," which is not provided in the input text but is referenced for the physical properties data.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document mentions "AQL=2.5%" for the watertight test, which refers to an Acceptance Quality Limit often used in sampling plans for quality control, but it does not specify the exact number of gloves or batches tested. Similarly, for other tests like length, width, and thickness, it provides minimums or averages but not the number of samples from which these were derived. For physical properties, it mentions "average results from Attachment C" without specifying the sample size.
• Data Provenance: The study was conducted by SPI GLOVES SDN. BHD. in Malaysia. The type is assumed to be prospective manufacturing quality control testing as part of the market approval process, rather than a retrospective analysis of existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this submission. The "ground truth" for examination gloves is established by objective measurements against quantitative physical and chemical standards (like ASTM D6319-00aE3 and FDA requirements) rather than expert opinion or interpretation.

4. Adjudication method for the test set

Not applicable. As the "ground truth" relies on objective measurements against established standards, there is no need for expert adjudication. Tests either pass or fail the specified criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are used for diagnostic imaging or similar applications where human readers interpret complex data, often with AI assistance. This submission is for a physical medical device (examination gloves) and does not involve AI or human interpretation of medical cases.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a physical medical device and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is based on established industry standards and regulatory requirements, specifically:

• ASTM D6319-00aE3 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• FDA 1000 ml watertight test requirements
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)

8. The sample size for the training set

Not applicable. This is a submission for a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

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